From Gilead to Cellect: A Comprehensive Analysis of Key Developments in ODP and Implications for PTA and PTE

Sponsored by: Fenwick & West LLP


Dr. James Evans is Senior Director and Assistant General Counsel in the Disputes Resolution Group at Regeneron Pharmaceuticals where he oversees worldwide patent litigation matters before various courts and regulatory agencies.  Prior to joining Regeneron, Dr. Evans’ practice focused on intellectual property litigation in the fields of pharmaceutical, biotechnology, and biologics patents.  Dr. Evans represented and counseled major innovative pharmaceutical companies on matters involving pharmaceutical compounds, immunotherapeutics (such as antibody composition, processing, and formulation), vectors, and vaccines. Dr. Evans received his J.D. from Quinnipiac University, cum laude, where he was the associate editor of the Health Law Journal. He earned his Ph.D. and M.S. in Immunobiology from Yale University. He earned his B.A. in Molecular, Cellular, and Developmental Biology from U.C. Santa Cruz, with High Honors.

Ryan Johnson is a nationally recognized patent litigator who represents clients in the pharmaceutical, biotech, consumer products, telecommunications and high-tech sectors in District Courts, the Federal Circuit Court of Appeals and the Patent Trial and Appeal Board (PTAB). He also routinely advises innovative companies on the patent-related aspects of acquisitions, licenses and other transactions. Ryan has extensive experience representing and counseling clients in the pharmaceutical industry, including at trial in their most important patent cases. He has litigated numerous cases arising under the Hatch-Waxman Act. His clients include leading biopharmaceutical companies like Pfizer, Novo Nordisk and UCB, as well as emerging companies striving to protect their IP and find a path to market. Through his many years of experience with the industry, Ryan understands the numerous regulatory, commercial and scientific challenges that these companies face, and this knowledge informs all facets of his representations. Beyond patent litigation, Ryan also has substantial experience representing pharmaceutical companies in antitrust matters and other complex commercial litigation.

Carl Morales applies his scientific and legal training toward acquiring, protecting and managing patent rights for clients in the biotechnology, chemistry, pharmaceutical and medical device industries. Carl has particular expertise in developing and prosecuting patent portfolios for FDA-approved or soon-to-be approved drug products, including for products involved or expected to be involved in litigation. He also devises and executes strategies to secure second and third generation patent coverage that extends pharmaceutical product exclusivity (e.g., formulation, dosing regimens and impurity profiles). FDA-approved drug products on which Carl has worked include Ibrance®, OxyContin®, Targiniq®, Fasenra™, Epanova®, Sitavig®, Oravig®, Bosulif®, Zetia® and Vytorin®. Carl has prepared and prosecuted patent applications in the U.S. Patent and Trademark Office and numerous foreign patent offices. His practice also includes pre-litigation case assessments; preparing patentability, validity, infringement and enforcement opinions; and due diligence evaluations. He is experienced in post-grant patent proceedings when product-critical patents are at stake, such as reissues, reexaminations and European oppositions. Carl has also prepared numerous patent term adjustment petitions and patent term extension applications and conducted Orange Book listing investigations.

Lulu Wang is vice president, head of intellectual property at Orna Therapeutics, a circular RNA biotechnology company building new treatments for cancers and genetic diseases. She leads the company’s global intellectual property strategy, leveraging over 10 years of experience building and defending pharmaceutical patent portfolios. Prior to joining Orna, Lulu was a patent litigator and prosecutor who represented innovative biotechnology and pharmaceutical companies, including AbbVie, Eli Lilly, and Novartis, in obtaining, defending, and challenging numerous patents. She also has extensive experience conducting patent due diligences for multimillion and multibillion dollar deals, including acquisitions and partnerships. Lulu earned her BA in biology from Harvard College, PhD in neurobiology from Harvard Medical School, and JD from Harvard Law School. She currently chairs the Patent Legislation Committee of the American Bar Association and previously chaired its Chemical and Life Sciences Patents Committee.